6944 Sprint Quattro
Defibrillation
6944 Sprint Quattro
ALL
Information

Device Survival Probability

6944_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo
% Survival 100.0 99.8 99.2 97.3 95.1 91.8 91.2 90.5 90.5 90.5
#   531 445 373 301 236 184 140 100 72 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 619
Cumulative Months of Follow-Up 33828
Number of Leads Active in Study 123
Information 29

Qualifying Complications

Conductor Fracture 16
Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 4
Oversensing 3
Other 0
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 17
Failure to Sense 3
Impedance Out of Range 10
Lead Dislodgement 24
Oversensing 18
Unspecified Clinical Failure 6
Information

Distribution Data

US Market Release2000-12-13
CE Approval Date1999-11-05
Registered USA Implants44776
Estimated Active USA Implants18283
US Market Release2000-12-13
CE Approval Date1999-11-05
Estimated WW Distribution117722
Information

USA Returned Product Analysis

Conductor Fracture 204
Insulation Breach 4
Crimp/Weld/Bond 1
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 393
Insulation Breach 14
Crimp/Weld/Bond 2
Other 8
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/Two Coils
More
Serial Number Prefix TDC
Lead Body Diameter 8.2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of April 10, 2020

www.medtronic.com/productperformance 751050